Nicotine Lozenge

ABSTRACT

A nicotine lozenge provided herein includes a body that is partially or wholly receivable in an oral cavity. The body includes a soluble-fiber matrix and nicotine or a derivative thereof dispersed in the soluble-fiber matrix. In some cases, a nicotine lozenge provided herein includes at least 40 weight percent of soluble fiber. In some cases, soluble fiber in a nicotine lozenge provided herein can include maltodextrin. The nicotine lozenge is adapted to release the nicotine or a derivative thereof from the body when the body is received within the oral cavity of an adult consumer and exposed to saliva. A method of making nicotine lozenges provided herein includes forming a molten mixture of at least 40 weight percent soluble fiber, nicotine, and less than 15 weight percent water while maintaining a mixture temperature of less than 150° C. and portioning the molten mixture into a plurality of nicotine lozenges. In some cases, the ingredients can be mixed to form the molten mixture in an extruder.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/142,048 filed on Apr. 29, 2016, which is a continuation of U.S.application Ser. No. 14/506,093 filed Oct. 3, 2014, which claims thebenefit of priority under 35 U.S.C. § 119(e) to U.S. Application No.61/886,386 filed Oct. 3, 2013. The prior application is incorporatedherein by reference in its entirety.

TECHNICAL FIELD

This document relates to nicotine lozenges and methods for makingnicotine lozenges. For example, a nicotine lozenge can include nicotinewithin a soluble-fiber matrix (e.g., maltodextrin).

BACKGROUND

Tobacco can be enjoyed by adult tobacco consumers in a variety of forms.Smoking tobacco is combusted and the aerosol either tasted or inhaled(e.g., in a cigarette, cigar, or pipe). Smokeless tobacco products arenot combusted and include: chewing tobacco, moist smokeless tobacco,snus, and dry snuff. Chewing tobacco is coarsely divided tobacco leafthat is typically packaged in a large pouch-like package and used in aplug or twist. Moist smokeless tobacco is a moist, more finely dividedtobacco that is provided in loose form or in pouch form and is typicallypackaged in round cans and used as a pinch or in a pouch placed betweenan adult tobacco consumer's cheek and gum. Snus is a heat treatedsmokeless tobacco. Dry snuff is finely ground tobacco that is placed inthe mouth or used nasally.

Nicotine is a component of various tobacco products. Over the years,however, various methods and systems have been developed for providingnicotine to adult consumers without the presence of tobacco planttissue. Some ways tobacco-free nicotine is provided include transdermalpatches, lozenges, and nicotine chewing gums.

Nicotine, or 3-(1-methyl-2-pyrrolidinyl) pyridine, is a tertiary aminewith the following structure:

Under ambient conditions, nicotine is an oily, volatile, hygroscopicliquid that is sensitive to light and air. Chemical and physicalproperties of nicotine present a number of processing and stabilityissues. For example, because nicotine is volatile, it may evaporateduring its incorporation into a gum or lozenge. In an effort to reducepotential processing and stability issues associated with the nicotinecompound, a number of nicotine complexes have been developed. Forexample, one method includes the preparation of a complex of nicotineand an ion exchange resin. A well-known complex that is currently usedin the commercially-available nicotine chewing gums is nicotinepolacrilex, which is a complex of nicotine and the cation exchange resinAMBERLITE 164.

SUMMARY

A nicotine lozenge provided herein provides a satisfying tactile and/orflavor experience. A nicotine lozenge provided herein includes a bodythat is at least partially receivable in an oral cavity of an adultconsumer. In some cases, a nicotine lozenge provided herein includes abody that is wholly receivable in an oral cavity. The body can include asoluble-fiber matrix and nicotine or a derivative thereof dispersed inthe soluble-fiber matrix. In some cases, the body can include unboundnicotine. In some cases, a nicotine lozenge provided herein includes atleast 40 weight percent of soluble fiber. In some cases, soluble fiberin a nicotine lozenge provided herein can include maltodextrin. Anicotine lozenge provided herein can be adapted to release the nicotineor a derivative thereof from the body when the body is received withinthe oral cavity of an adult consumer and exposed to saliva. A body of anicotine lozenge provided herein can be a single phase structure. Insome cases, the body of a nicotine lozenge provided herein can beamorphous.

A method of making nicotine lozenges provided herein includes forming amolten mixture of at least 40 weight percent soluble fiber, nicotine,and less than 15 weight percent water while maintaining a mixturetemperature of less than 150° C. and portioning the molten mixture intoa plurality of nicotine lozenges. In some cases, the ingredients can bemixed to form the molten mixture in an extruder, flattened into a sheetof a predetermined thickness as it leaves the extruder, and individualnicotine lozenges cut from the sheet before the sheet cools below theglass transition temperature range of the molten mixture. Unlike atraditional lozenge, which incorporates sugars or sugar alcohols thatare heated to a temperature such that caramelization occurs, methodsprovided herein include heating the molten mixture to form a solution ofnicotine and water (and optionally other ingredients) in the solublefiber without significant crosslinking. In some cases, additionaladditives can be added that are dispersed within the soluble fibermatrix, but not in solution with the soluble fiber. Because nicotinedegradation can be accelerated when exposed to elevated temperaturesover extended periods of time, the temperature of a molten mixtureprovided herein can be maintained at a temperature of 150° C. or belowover a residence time of five to ten minutes or less (for example if anextrusion process is utilized). In some cases, a molten mixture providedherein is heated to a temperature of between 80° C. and 150° C. In somecases, a molten mixture provided herein is heated to a temperature ofbetween 100° C. and 110° C. When cooled below its glass transitiontemperature, a molten mixture provided herein solidifies into anamorphous, non-porous, soluble fiber matrix containing nicotine. Becausethe soluble fibers do not become cross-linked, the soluble fibers remainsoluble and thus dissolve when placed in an adult consumer's mouth.

A nicotine lozenge body can be rigid and brittle. In some cases, a bodyprovided herein can have a glass transition temperature greater than 37°C. In some cases, a body provided herein can have a glass transitiontemperature of between 50° C. and 120° C. In some cases, a body providedherein can have a glass transition temperature of between 80° C. and100° C. In some cases, a body provided herein having 90 weight percentmaltodextrin can have a glass transition temperature of approximately98° C. A nicotine lozenge provided herein can have a coating over thebody. In some cases, the body of a nicotine lozenge provided herein canbe non-porous.

A nicotine lozenge body can include at least 40 weight percent ofsoluble fiber. In some cases, the nicotine lozenge body includes atleast 50 weight percent of soluble fiber. In some cases, the nicotinelozenge body includes at least 60 weight percent of soluble fiber. Insome cases, the nicotine lozenge body includes at least 70 weightpercent of soluble fiber. In some cases, the nicotine lozenge bodyincludes at least 75 weight percent of soluble fiber. In some cases, thenicotine lozenge body includes at least 80 weight percent of solublefiber. In some cases, the nicotine lozenge body includes at least 85weight percent of soluble fiber. In some cases, the nicotine lozengebody includes at least 90 weight percent of soluble fiber. In somecases, the nicotine lozenge body includes at least 95% weight percent ofsoluble fiber. In some cases, the soluble fiber can includemaltodextrin, psylliums, inulin, arabinoxylans, cellulose, and manyother plant components such as resistant starch, resistant dextrins,lignin, pectins, beta-glucans, and oligosaccharides or a combinationthereof. In some cases, a nicotine lozenge body can include at least 40weight percent maltodextrin. In some cases, the nicotine lozenge bodyincludes at least 50 weight percent maltodextrin. In some cases, thenicotine lozenge body includes at least 60 weight percent maltodextrin.In some cases, the nicotine lozenge body includes at least 70 weightpercent maltodextrin. In some cases, the nicotine lozenge body includesat least 75 weight percent maltodextrin. In some cases, the nicotinelozenge body includes at least 80 weight percent maltodextrin. In somecases, the nicotine lozenge body includes at least 85 weight percentmaltodextrin. In some cases, the nicotine lozenge body includes at least90 weight percent maltodextrin. In some cases, the nicotine lozenge bodyincludes at least 95 weight percent maltodextrin.

In some cases, a nicotine lozenge provided herein can include adigestion-resistant soluble fiber (e.g., maltodextrins.) Suitablemaltodextrins include those that are soluble in water up to 70% at 20°C., have a viscosity of about 15 cps for a 30% solution at 30° C., a DEin the range of about 6-16, and contain random α-1,2, α-1,3, α-1,4,β-1,2, β-1,3 and β-1,4 glucose linkages in addition to the normal α-1,4glucose linkages found in partially hydrolyzed starch. See, e.g., U.S.Pat. Nos. 5,410,035; 5,380,717. For example, Fibersol®-2 is amaltodextrin of DE 6-10 processed from corn starch using hydrochloricacid and enzymes, which can be used as the soluble fiber in a nicotinelozenge provided herein. Fibersol®-2 is partially indigestible becausehuman digestive enzymes are incapable of digesting β1,2, β1,3 and β1,6glucose bonds. See, e.g., U.S. Pat. No. 6,203,842. Other starch sourcessuch as potato, rice, wheat, barley, peas, beans, lentils, oats, ortapioca can be processed to form digestion-resistant soluble fiber. Adigestion resistant soluble fiber includes starch linkages that cannotbe hydrolyzed by enzymes of the human digestive tract. Soluble fiberused in a nicotine lozenge provided herein can be a soluble fibergenerally recognized as safe (“GRAS”) by the Food and DrugAdministration or another appropriate private, state, or nationalregulatory agency.

A nicotine lozenge provided herein can, in some cases, include up to 15weight percent water. In some cases, a nicotine lozenge provided hereincan include between 2 weight percent and 15 weight percent water. Insome cases, a nicotine lozenge provided herein can include between 3weight percent and 10 weight percent water. In some cases, a nicotinelozenge provided herein can include between 4 weight percent and 7weight percent water.

Nicotine or derivatives thereof added to a nicotine lozenge providedherein can be in any suitable form. In some cases, a nicotine lozengeprovided herein includes between 0.1 mg and 20 mg nicotine. In somecases, nicotine in a nicotine lozenge provided herein includestobacco-derived nicotine. In some cases, nicotine in a nicotine lozengeprovided herein includes synthetic nicotine. A nicotine lozenge providedherein, in some cases, can be substantially free of tobacco planttissue. A nicotine lozenge provided herein can be substantially free ofcellulose fibers. In some cases, a nicotine lozenge provided hereinincludes less than 10 weight percent of cellulose fibers.

A nicotine lozenge provided herein can include a sweetener dispersedtherein. Suitable sweeteners include saccharine, sucralose, aspartame,acesulfame potassium, and combinations thereof. In some cases, anicotine lozenge provided herein can be substantially free of sugars andsugar alcohols. For example, a nicotine lozenge can be substantiallyfree of sugars and sugar alcohols, but include non-nutritive sweeteners.In some cases, a nicotine lozenge provided herein can includenon-caramelized sugars and/or sugar alcohols in a percentage of no morethan 25 weight percent. For example, mannitol and/or sorbitol can beadded to reduce the glass transition temperature of a molten mixtureprovided herein. When included, sugars and sugar alcohols in a moltenmixture form a solution with the soluble fiber. Sugars and sugaralcohols can alter the glass transition temperature of a molten mixtureprovided herein. When cooled below the glass transition temperature, asolution of soluble fiber and sugar alcohols remains an amorphous,single-phase, non-crosslinked structure.

A nicotine lozenge provided herein can include flavorants. Theflavorants can be natural or artificial. Flavorants can be selected fromthe following: licorice, wintergreen, cherry and berry type flavorants,Drambuie, bourbon, scotch, whiskey, spearmint, peppermint, lavender,cinnamon, cardamon, apium graveolents, clove, cascarilla, nutmeg,sandalwood, bergamot, geranium, honey essence, rose oil, vanilla, lemonoil, orange oil, Japanese mint, cassia, caraway, cognac, jasmin,chamomile, menthol, ylang ylang, sage, fennel, pimenta, ginger, anise,chai, coriander, coffee, mint oils from a species of the genus Mentha,cocoa, and combinations thereof. Synthetic flavorants can also be used.In certain cases, a combination of flavorants can be combined to imitatea tobacco flavor. The particular combination of flavorants can beselected from flavorants that are GRAS in a particular country, such asthe United States. Flavorants can also be included in the nicotinelozenge as encapsulated flavorants.

A nicotine lozenge provided herein can include a plasticizer dispersedin the soluble-fiber matrix. For example, the plasticizer can bepropylene glycol, triacetin, glycerin, vegetable oil, partiallyhydrogenated oil, triglycerides, triacetin, or a combination thereof.

A body of a nicotine lozenge provided herein can have a variety ofdifferent shapes, some of which include disk, shield, heart, rectangle,and square. In some cases, a body of a nicotine lozenge provided hereincan have rounded corners. In some cases, the body of the nicotinelozenge can be spherical. According to certain cases, the body can havea length or width of between 1 mm and 25 mm and a thickness of between 1mm and 25 mm. In some cases, the body can have a length or width ofbetween 5 mm and 15 mm and a thickness of between 2 mm and 5 mm. In somecases, a nicotine lozenge provided herein can include a colorant. Forexample, a body of a nicotine lozenge provided herein can includetitanium dioxide, which can provide the body with a white color. In somecases, a coating on the body can include a colorant.

A method of forming nicotine lozenges can include forming a moltenmixture of at least 40 weight percent soluble fiber, nicotine, and lessthan 15 weight percent water, while maintaining a mixture temperature ofless than 150° C. In some cases, the molten mixture includes at lessthan 13 weight percent, less than 10 weight percent, less than 8 weightpercent, less than 7 weight percent, less than 6 weight percent, or lessthan 5 weight percent water. In some cases, the molten mixture includesat least 3 weight percent, at least 4 weight percent, at least 6 weightpercent, or at least 7 weight percent water. In addition to nicotine,water, and soluble fiber (e.g., maltodextrin), a molten mixture providedherein can include one or more additives selected from colorants,sweeteners, flavorants, plasticizers, antioxidants, and combinationsthereof. In some cases, the molten mixture is substantially free ofcellulose fiber, tobacco plant tissue, and/or sugar alcohols.

In some cases, the molten mixture provided herein is formed in anextruder. The extruder can be a multi-staged extruder having differentsections that are heated to different temperatures and/or have differentingredients introduced. In some cases, an extruder provided herein caninclude multiple stages and can be used in a method provided herein in aprocess where the maximum temperature in any stage is no more than 150°C. (e.g., no more than 150° C., no more than 110° C., or no more than105° C.). In some cases, the molten mixture can be heated to a maximumtemperature of greater than the molten mixture's Tg and less than 150°C.

Portioning the molten mixture provided herein can be accomplished usingany suitable method. In some cases, the molten mixture can be formedinto a sheet of a predetermined thickness as it comes out of theextruder and individual nicotine lozenges cut from the sheet with astamping die. A method provided herein can further include coolingnicotine lozenges and packaging nicotine lozenges.

The details of one or more embodiments of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages of thesubject matter will become apparent from the description, the drawings,and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary nicotine lozenge providedherein.

FIGS. 1A-1O illustrates various additional exemplary shapes of nicotinelozenges provided herein.

FIG. 2 is a differential scanning calorimetry data for an exemplarymolten mixture provided herein.

FIG. 2A is a modulated differential scanning calorimetry data for anexemplary molten mixture provided herein.

FIGS. 3A-3D depicts X-ray microtomography images from an exemplaryextruded nicotine lozenge provided herein.

FIG. 4 is a dynamic mechanical analysis (DMA) of an exemplary extrudednicotine lozenge provided herein.

FIG. 5 depicts an exemplary process flow diagram for making nicotinelozenges provided herein.

DETAILED DESCRIPTION

Nicotine lozenges described herein include nicotine or a derivativethereof in a soluble-fiber matrix. Nicotine or a derivative thereof canbe dispersed in the soluble-fiber matrix such that the nicotine orderivative thereof is released from the nicotine lozenge as it dissolveswhen the nicotine lozenge is received within the oral cavity and exposedto saliva. The nicotine lozenges described herein can provide afavorable additive release profile and tactile experience. In somecases, a nicotine lozenge provided herein includes unbound nicotine insolution with soluble fiber of the matrix.

In addition to nicotine and/or derivatives thereof, one or moreadditional additives can be included in a nicotine lozenge providedherein and adapted to be released from the nicotine lozenge when thenicotine lozenge is placed in an oral cavity. In some cases, a nicotinelozenge provided herein can include a combination of nicotine,sweeteners, and flavorants to mimic the flavor profile and tactileexperience of certain tobacco products.

A nicotine lozenge provided herein can take up to 1 hour to dissolvewhen placed in an adult consumer's mouth. In some cases, a nicotinelozenge provided herein can take between 1 minute and 30 minutes todissolve when placed in an adult consumer's mouth if the adult consumerdoes not masticate the nicotine lozenge. In some cases, a nicotinelozenge provided herein can take between 2 minutes and 15 minutes todissolve when placed in an adult consumer's mouth if the adult consumerdoes not masticate the nicotine lozenge. In some cases, a nicotinelozenge can be substantially free of tobacco plant tissue. As usedherein, the term “tobacco plant tissue” refers to processed ornon-processed cellulosic parts (e.g., leaves, stems) of a member of thegenus Nicotiana, but does not include extracts of tobacco (e.g.,tobacco-derived nicotine). As used herein, “substantially free oftobacco plant tissue” means that the product includes less than 0.5weight percent of tobacco plant tissue. For example, a nicotine lozengeprovided herein can include one or more organoleptic componentsextracted from raw or processed tobacco, yet be substantially free oftobacco plant tissue. In some cases, a nicotine lozenge provided hereincan include one or more organoleptic components extracted from raw orprocessed tobacco, yet include no tobacco plant tissue.

Nicotine lozenges provided herein can be substantially free of cellulosefibers. In some cases, a nicotine lozenge provided herein includes up to10 weight percent cellulosic fibers. Cellulosic fibers used in anicotine lozenge provided herein can have an average fiber size of lessthan 200 micrometers. In particular cases, cellulosic fibers in anicotine lozenge provided herein have sizes between 25 and 125micrometers.

In addition to nicotine, sweeteners, and flavorants, the nicotinelozenge can also include fillers, plasticizers, antioxidants, colorants,and/or processing aids. Fillers can also be included in thesoluble-fiber matrix to alter the texture or pliability of the nicotinelozenge. The soluble-fiber matrix can also include plasticizers (e.g.,propylene glycol), which can increase the softness of a nicotine lozengeprovided herein. Antioxidants can be used to preserve nicotine in thenicotine lozenge. Processing aids can also be present in the nicotinelozenge and be used to facilitate shaping processes.

Nicotine Lozenge Shapes and Packaging

FIG. 1 depicts an example of a nicotine lozenge 110. The nicotinelozenge 110 has a rounded shield shape. For example, nicotine lozenge110 can have a diameter of about 16 mm, a width of 14 mm, and athickness of about 11 mm.

Referring now to FIGS. 1A-1N, nicotine lozenges provided herein can bemolded into any desired shape. For example, referring to FIGS. 1A-1L,nicotine lozenges 110A-L can be formed in shapes that promotes improvedpositioning in the oral cavity, improved packaging characteristics, orboth. In some circumstances, nicotine lozenges 110A-L can be configuredto be: (A) an elliptical-shaped nicotine lozenge 110A ; (B) an elongatedelliptical-shaped nicotine lozenge 110B; (C) semi-circular nicotinelozenge 110C; (D) square or rectangular-shaped nicotine lozenge 110D;(E) football-shaped nicotine lozenge 110E; (F) elongatedrectangular-shaped nicotine lozenge 110F; (G) boomerang-shaped nicotinelozenge 110G; (H) rounded-edge rectangular-shaped nicotine lozenge 110H;(I) teardrop- or comma-shaped nicotine lozenge 110I; (J) bowtie-shapednicotine lozenge 110J; (K) peanut-shaped nicotine lozenge 110K; and (L)flat shield-shaped nicotine lozenge. Alternatively, the nicotine lozengecan have different thicknesses or dimensionality, such that a beveledarticle (e.g., a wedge) is produced (see, for example, product 110Mdepicted in FIG. 1M) or a hemi-spherical shape is produced.

In addition or in the alternative to flavorants being included withinthe soluble-fiber matrix, flavorants can be included on an exterior ofthe nicotine lozenge 110. For example, referring to FIG. 1N, forexample, some embodiments of a nicotine lozenge 110N can be equippedwith flavor strips 116.

Referring to FIG. 10, particular embodiments of the nicotine lozenge 110can be embossed or stamped with a design (e.g., a logo, an image, or thelike). For example, the nicotine lozenge 110O can be embossed or stampedwith any type of design 117 including, but not limited to, a trademark,a product name, or any type of image. The design 117 can be formeddirectly into the nicotine lozenge, arranged along the exterior of theproduct 110O. The design 117 can also be embossed or stamped into thoseembodiments with a dissolvable film 116 applied thereto.

In some cases, the nicotine lozenge 110 or lozenges 110A-O can bewrapped or coated in an edible or dissolvable film, which may be opaque,substantially transparent, or translucent. The dissolvable film canreadily dissipate when the nicotine lozenge 110 is placed in an oralcavity. In some cases, the nicotine lozenge 110 can be coated with amouth-stable material. Exemplary coating materials include Carnuba wax,Beeswax, gelatin, acetylated monoglyceride, starch (e.g., native potatostarch, high amylose starch, hydroxypropylated potato starch), Zein,Shellac, ethyl cellulose, methylcellulose, hydroxypropylmethylcellulose, carboxymethyl cellulose, and combinations thereof.Additives, such as miglycol, titanium dioxide, kaoline, bentonite, canbe incorporated into the coating material to improve oxygen or moisturebarrier and mechanical properties for the coating or film. For example,a coating can include a combination of gelatin and methylcellulose orgelatin and hydroxymethylcellulose. In some cases, the coating cancontain sugar alcohols such as sorbitol, mannitol, xylitol, erythritol),disaccharide-derived (e.g., isomalt, lactitol, maltitol), orpolysaccharide-derived mixtures (e.g., maltitol syrup, hydrogenatedstarch hydrolysates [HSH]) or combinations thereof. In some cases acoating material can contain sugar alcohols and hydroxymethylcellulose,gelatin, wax, with additives. In some cases, a coating material caninclude a plasticizer. In some case, a coating can include a colorant, aflavorant, and/or a one or more of the additives discussed above. Forexample, a coating can include nicotine to provide a user with readilyavailable nicotine. In some cases, the body of a nicotine lozengeprovided herein can have surfaces roughened to improve the adherence ofa coating. In some cases, a coating can provide a glossy or semi-glossyappearance, a smooth surface, and/or an appealing visual aesthetic(e.g., a nice color). In some cases, the coating (e.g., a Beeswax, Zein,acetylated monoglyceride, and/or hydroxypropylated potato starchcoating) can provide a soft mouth feel. In some cases, the coating(e.g., a methylcellulose, hydroxypropyl methylcellulose, carboxymethylcellulose, ethyl cellulose, and/or gelatin coating) can provide a hardouter coating.

One or more nicotine lozenges 110 can be packaged in a variety ofconventional and non-conventional manners. For example, a plurality ofnicotine lozenges 110 can be packaged in a container having a lid. Insome cases, a plurality of nicotine lozenges 110 can be stacked andpackaged in a paper, plastic, and/or aluminum foil tube. The packagingcan have a child-resistant lid.

Nicotine Lozenge Properties

The nicotine lozenge 110 can provide a favorable tactile experience(e.g., mouth feel). The nicotine lozenge 110 can also retain its shapeduring processing, shipping, handling, and optionally while placed inthe mouth. In some cases, the nicotine lozenge 110 can be rigid. In somecases, a nicotine lozenge 110 can be brittle such that an adult consumercan crunch or masticate the nicotine lozenge 110 in the adult consumer'smouth. A nicotine lozenge 110 provided herein can be non-porous.Manipulation of a nicotine lozenge 110 provided herein to increase theexposure of surfaces to saliva can accelerate a dissolution rate.

A nicotine lozenge 110 provided herein can have a glass transitiontemperature (Tg) that is in the range of 50° C. to 120° C. (i.e., about122° F. to about 248° F.), depending on formulations (e.g. soluble fibertype and weight percentage, water content, total flavor weightpercentage, etc.) and processing conditions used to form the nicotinelozenge 110. The Tg can impact the preferred operating temperature usedto form a solution of the soluble fiber, nicotine, and otheringredients. By changing the soluble fiber weight percentage and type,the Tg range can be altered. In some cases, when a nicotine lozengeprovided herein is placed in an adult consumer's mouth, the nicotinelozenge is not soft, but remains as an amorphous glassy state, as theadult consumer's body temperature is below the glass transitiontemperature range of the product. Nicotine lozenges provided herein canremain in a glassy state throughout the duration of its shelf life(e.g., at least 2 months, at least 6 months, at least 1 year, or atleast 2 years). The Tg temperature can also impact a sensorialexperience provided by a nicotine lozenge provided herein. For example,a glass transition temperature above body temperature can impede anicotine lozenge from becoming sticky when placed in the adultconsumers' mouth.

A nicotine lozenge 110 provided herein can have any desirable color. Insome cases, a nicotine lozenge 110 provided herein can be translucentand have an off-white color. In some cases, a colorant can be includedto provide a desired visual appearance. In some cases, natural andartificial colorants can be added to a soluble-fiber matrix of anicotine lozenge 110. In some cases, a colorant can make a body of anicotine lozenge opaque. For example, titanium dioxide can be added to asoluble-fiber matrix to produce an opaque white nicotine lozenge.Encapsulated flavors can be added during the extrusion process to createspeckles, patterns or dots within the nicotine lozenge or on a surfaceof a nicotine lozenge 110. In some cases, a coating applied to a body ofa nicotine lozenge can provide a desirable color.

A nicotine lozenge as described herein was made using about 80-85 weightpercent Fibersol®-2 digestion resistant maltodextrin; between 6-7 weightpercent water; and other ingredients that included nicotine, flavors,sweeteners, antioxidants, colorant, plasticizer, and processing aides. Atest of the nicotine lozenge demonstrated that nicotine degradants andimpurities after sixteen weeks were non-detectable. For example, asshown in Table 1, all nicotine degradants at week 16 were non-detectableunder controlled conditions of 25° C., 65% relative humidity, andatmospheric pressure.

TABLE 1 % Relative to Nicotine Concentration of Nicotine Lozenge at week16 (Average, n = 3) Myosmine Nornicotine Anabasine Cotinine AnatabineNicotine-Oxide b-Nicotyrine ND ND ND ND ND ND ND

FIG. 2 shows a differential scanning calorimetry (DSC) data for anexemplary molten mixture provided herein, a nicotine lozenge that has aTg range of between 50° C. and 120° C. By having the lower limit of theTg range higher than body temperature (i.e., about 37° C.), nicotinelozenges provided here can remain rigid and non-sticky when placed in anadult consumer's mouth. A Tg temperature for a particular molten mixturecan guide a preferred operating temperature range for the extrusionprocess. The process is designed to stay well below the decompositiontemperature of −257° C. as measured by DSC (See FIG. 2). One componentof the mixtures that affects Tg range is the soluble fiber weightpercentage and type. For example, FIG. 2A depicts the modulated DSC foran exemplary mixture, provided herein, which shows a Tg for a nicotinelozenge body that has a Tg of 98° C. By changing the soluble fiberweight percentage and type, the Tg range can be altered. When a nicotinelozenge provided herein is placed in an adult consumer's mouth, anicotine lozenge can remain as an amorphous glassy state, as the bodytemperature is below the glass transition temperature range of thenicotine lozenge provided herein. A nicotine lozenge provided herein canbe designed to remain in a glassy state throughout the duration of itsshelf life for the product. In some cases, a nicotine lozenge providedherein can have a Tg that impacts the sensorial experience. For example,a nicotine lozenge provided herein having a Tg range greater than bodytemperature and can remain non-sticky when placed in an adult consumer'smouth.

The structure can be non-porous. FIGS. 3A-3D depict X-raymicrotomography images from an exemplary extruded nicotine lozengeprovided herein, which shows that the structure is non-porous.

FIG. 4 is a dynamic mechanical analysis (DMA) of an exemplary extrudednicotine lozenge provided herein. The storage modulus (blue line,diamond legend) is correlated to the stiffness (E′) of the material andthis informs where the mixture viscosity is sufficiently pliable forprocessing (i.e. rubbery state). The extrusion temperature operatingrange is between 100° C. and 150° C.

Soluble Fibers

Soluble fiber dissolves in water at ambient temperature. Insoluble fiberdoes not dissolve in water at ambient temperature. Soluble fibers canattract water and form a gel. Not only are many soluble fibers safe forconsumption, but some soluble fibers are used as a dietary supplement.As a dietary supplement, soluble fiber can slow down digestion and delaythe emptying of a stomach. Instead of using soluble fiber as a mereadditive, however, nicotine lozenges provided herein include a matrix ofsoluble fiber, which can dissolve to provide access to nicotine (andoptionally other additives) included in the soluble-fiber matrix. Anysuitable soluble fiber or combination of soluble fibers can be used toform a soluble-fiber matrix provided herein. Suitable soluble fibersinclude maltodextrin, psyllium, pectin, guar gum, gum arabic, inulin,arabinoxylans, cellulose, and many other plant components such asresistant starch, resistant dextrins, lignin, pectins, beta-glucans, andoligosaccharides or a combination thereof. In some cases, a nicotinelozenge provided herein can include a digestion-resistant soluble fiber.A digestion resistant soluble fiber can include starch linkages thatremain undigested by enzymes of the human digestive tract. In somecases, a nicotine lozenge provided herein can include adigestion-resistant maltodextrin. In some cases, a digestion-resistantmaltodextrin can be derived from maze. Suitable maltodextrins caninclude those that are soluble in water up to 70% at 20° C., have aviscosity of about 15 cps for a 30% solution at 30° C., a DE in therange of about 6-16, and contain random α-1,2, α-1,3, α-1,4, β-1,2,β-1,3 and β-1,4 glucose linkages in addition to the normal α-1,4 glucoselinkages found in partially hydrolyzed starch. See, e.g., U.S. Pat. Nos.5,410,035; 5,380,717, which are hereby incorporated by reference. Forexample, Fibersol®-2 is a maltodextrin of DE 6-10 processed from cornstarch using hydrochloric acid and enzymes, which can be used as thesoluble fiber in a nicotine lozenge provided herein. Fibersol®-2 ispartially indigestible because human digestive enzymes are incapable ofdigesting β1,2, β1,3 and β1,6 glucose bonds. See, e.g., U.S. Pat. No.6,203,842. Other starch sources such as potato, rice, wheat, barley,peas, beans, lentils, oats, or tapioca can be processed to formdigestion-resistant soluble fiber. A digestion resistant soluble fiberincludes starch linkages that cannot be hydrolyzed by enzymes of thehuman digestive tract. In some cases, suitable soluble fibers includePinefiber, Pinefiber C, Dexflow and Pineflow as discussed in U.S. Pat.No. 5,236,719, which is hereby incorporated by reference. Soluble fiberused in a nicotine lozenge provided herein can be GRAS by the Food andDrug Administration or another appropriate private, state, or nationalregulatory agency.

A nicotine lozenge body can include at least 40 weight percent ofsoluble fiber, at least 50 weight percent of soluble fiber, at least 60weight percent of soluble, at least 70 weight percent of soluble fiber,at least 75 weight percent of soluble fiber, at least 80 weight percentof soluble fiber, at least 85 weight percent of soluble fiber, at least90 weight percent of soluble fiber, or at least 95% weight percent ofsoluble fiber. In some cases, a nicotine lozenge body can include atleast 40 weight percent maltodextrin, at least 50 weight percentmaltodextrin, at least 60 weight percent maltodextrin, at least 70weight percent maltodextrin, at least 75 weight percent maltodextrin, atleast 80 weight percent maltodextrin, at least 85 weight percentmaltodextrin, at least 90 weight percent maltodextrin, or at least 95weight percent maltodextrin. In some cases, a nicotine lozenge body caninclude less than 95 weight percent less than 90 weight percentmaltodextrin, less than 85 weight percent maltodextrin, or less than 80weight percent maltodextrin. In some cases, a nicotine lozenge body caninclude at least 40 weight percent digestion-resistant maltodextrin, atleast 50 weight percent digestion-resistant maltodextrin, at least 60weight percent digestion-resistant maltodextrin, at least 70 weightpercent digestion-resistant maltodextrin, at least 75 weight percentdigestion-resistant maltodextrin, at least 80 weight percentdigestion-resistant maltodextrin, at least 85 weight percentdigestion-resistant maltodextrin, at least 90 weight percentdigestion-resistant maltodextrin, or at least 95 weight percentdigestion-resistant maltodextrin.

Nicotine

Nicotine within a nicotine lozenge provided herein can betobacco-derived nicotine, synthetic nicotine, or a combination thereof.In some cases, the nicotine can be liquid nicotine. Liquid nicotine canbe purchased from commercial sources, whether tobacco-derived orsynthetic. In some cases, a nicotine lozenge provided herein includesbetween 0.1 mg and 20.0 mg of nicotine. In some cases, a nicotinelozenge provided herein includes between 0.5 mg and 10.0 mg of nicotine.In some cases, a nicotine lozenge provided herein includes between 1.0mg and 3.0 mg of nicotine.

Tobacco-derived nicotine can include one or more other tobaccoorganoleptic components other than nicotine. The tobacco-derivednicotine can be extracted from raw (e.g., green leaf) tobacco and/orprocessed tobacco. Processed tobaccos can include fermented andunfermented tobaccos, dark air-cured, dark fire cured, burley, fluecured, and cigar filler or wrapper, as well as the products from thewhole leaf stemming operation. The tobacco can also be conditioned byheating, sweating and/or pasteurizing steps as described in U.S.Publication Nos. 2004/0118422 or 2005/0178398. Fermenting typically ischaracterized by high initial moisture content, heat generation, and a10 to 20% loss of dry weight. See, e.g., U.S. Pat. Nos. 4,528,993;4,660,577; 4,848,373; and 5,372,149. By processing the tobacco prior toextracting nicotine and other organoleptic components, thetobacco-derived nicotine may include ingredients that provide afavorable experience. The tobacco-derived nicotine can be obtained bymixing cured tobacco or cured and fermented tobacco with water oranother solvent (e.g., ethanol) followed by removing the insolubletobacco material. The tobacco extract may be further concentrated orpurified. In some cases, select tobacco constituents can be removed.Nicotine can also be extracted from tobacco in the methods described inthe following patents: U.S. Pat. Nos. 2,162,738; 3,139,436; 3,396,735;4,153,063; 4,448,208; and 5,487,792.

The nicotine can also be purchased from commercial sources, whethertobacco-derived or synthetic. In some cases, a nicotine lozenge providedherein can include a derivative of nicotine (e.g., a salt of nicotine).

Liquid nicotine can be pure, substantially pure, or diluted prior tomixing it with the soluble fiber. A diluting step is optional. In somecases, liquid nicotine is diluted to a concentration of between 1 weightpercent and 75 weight percent prior to mixing the liquid nicotine withthe soluble fiber. In some cases, liquid nicotine is diluted to aconcentration of between 2 weight percent and 50 weight percent prior tomixing the liquid nicotine with the soluble fiber. In some cases, liquidnicotine is diluted to a concentration of between 5 weight percent and25 weight percent prior to mixing the liquid nicotine with the solublefiber. For example, liquid nicotine can be diluted to a concentration ofabout 10 weight percent prior to mixing the liquid nicotine with thesoluble fiber.

Additional Additives

A variety of additives other than nicotine or derivatives thereof can beincluded in a nicotine lozenge provided herein. The additives caninclude non-nicotine alkaloids, minerals, vitamins, dietary supplements,nutraceuticals, energizing agents, soothing agents, coloring agents,amino acids, chemsthetic agent, antioxidants, food grade emulsifiers, pHmodifiers, botanicals (e.g., green tea), teeth whitening (e.g., SHMP),therapeutic agents, sweeteners, flavorants, and combinations thereof. Insome cases, the additives can further include one or more non-nutritivesweeteners, one or more antioxidants, and one or more flavorants. Withcertain combinations of nicotine, sweeteners, and flavorants, a nicotinelozenge provided herein may provide a flavor profile and tactileexperience similar to certain tobacco products.

Antioxidants

A nicotine lozenge 110 provided herein can include one or moreantioxidants. Antioxidants can result in a significant reduction in theconversion of nicotine into nicotine-N-oxide when compared to nicotineproducts without antioxidants. In some cases, a nicotine lozengeprovided herein can include 0.01 and 5.00 weight percent antioxidant,between 0.05 and 1.0 weight percent antioxidant, between 0.10 and 0.75weigh percent antioxidant, or between 0.15 and 0.5 weight percentantioxidant. Suitable examples of antioxidants include ascorbylpalmitate (a vitamin C ester), BHT, ascorbic acid (Vitamin C), andsodium ascorbate (Vitamin C salt). In some cases, monosterol citrate,tocopherols, propyl gallate, tertiary butylhydroquinone (TBHQ),butylated hydroxyanisole (BHA), Vitamin E, or a derivative thereof canbe used as the antioxidant. For example, ascorbyl palmitate can be theantioxidant in the formulations listed in Table I. Antioxidants can beincorporated into the soluble-fiber matrix (e.g., maltodextrin) during amixing process (e.g., added to an extruder mixing the ingredients).

Sweeteners

A variety of synthetic and/or natural sweeteners can be used asadditives in a nicotine lozenge 110 provided herein. Suitable naturalsweeteners include sugars, for example, monosaccharides, disaccharides,and/or polysaccharide sugars, and/or mixtures of two or more sugars. Insome cases, a nicotine lozenge 110 provided herein includes one or moreof the following: sucrose or table sugar; honey or a mixture of lowmolecular weight sugars not including sucrose; glucose or grape sugar orcorn sugar or dextrose; molasses; corn sweetener; corn syrup or glucosesyrup; fructose or fruit sugar; lactose or milk sugar; maltose or maltsugar or maltobiose; sorghum syrup; mannitol or manna sugar; sorbitol ord-sorbite or d-sobitol; fruit juice concentrate; and/or mixtures orblends of one or more of these ingredients. A nicotine lozenge providedherein an also include non-nutritive sweeteners. Suitable non-nutritivesweeteners include: stevia, saccharin; aspartame; sucralose; oracesulfame potassium.

Flavorants

The nicotine lozenge provided herein can optionally include one or moreflavorants. The flavorants can be natural or artificial. For example,suitable flavorants include wintergreen, cherry and berry typeflavorants, various liqueurs and liquors (such as Dramboui, bourbon,scotch, and whiskey) spearmint, peppermint, lavender, cinnamon,cardamon, apium graveolents, clove, cascarilla, nutmeg, sandalwood,bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orangeoil, Japanese mint, cassia, caraway, cognac, jasmin, chamomile, menthol,ylang ylang, sage, fennel, pimenta, ginger, anise, chai, coriander,coffee, liquorish, and mint oils from a species of the genus Mentha, andencapsulated flavors. Mint oils useful in particular embodiments of anicotine lozenge 110 provided herein include spearmint and peppermint.Synthetic flavorants can also be used. In some cases, a combination offlavorants can be combined to imitate a tobacco flavor. The particularcombination of flavorants can be selected from flavorants that are GRASin a particular country, such as the United States. Flavorants can alsobe included in the nicotine lozenge as encapsulated flavorants.

In some cases, the flavorants in a nicotine lozenge provided herein arelimited to less than 20 weight percent in sum. In some cases, theflavorants in the nicotine lozenge 110 are limited to be less than 10weight percent in sum. For example, certain flavorants can be includedin the nicotine lozenge 110 in amounts of about 1 weight percent to 5weight percent.

Cellulosic Fibers

Nicotine lozenges provided herein can optionally include cellulosicfibers within the soluble-fiber matrix. In some cases, nicotine lozenges110 provided herein are substantially free of cellulosic fibers. As usedhere, “substantially free of cellulosic fibers” means that a nicotinelozenge provided herein has less than 0.5 weight percent cellulosicfibers. In some cases, nicotine lozenges 110 provided herein include upto 10 weight percent cellulosic fibers. Cellulosic fibers can be mixedwith molten mixtures including soluble fibers to form a nicotine lozengeprovided herein. Additives can be absorbed in cellulosic fibers. In somecases, the fibers are hydrophilic such that water-soluble additives canbe wicked by the fibers. Cellulosic fibers can be derived from planttissue. Suitable sources for cellulosic fibers include wood pulp,cotton, sugar beets, bran, citrus pulp fiber, switch grass and othergrasses, Salix (willow), tea, and Populus (poplar). In some cases, thecellulosic fibers can be plant tissue comprising various naturalflavors, sweeteners, or active ingredients. Cellulosic fibers can have avariety of dimensions. In some cases, cellulosic fibers in a nicotinelozenge 110 provided herein can be processed to have an average fibersize of less than 200 micrometers. In some cases, cellulosic fibers in anicotine lozenge 110 provided herein have an average fiber length ofbetween 25 and 125 micrometers. In some cases, cellulosic fibers areprocessed to have a size of 75 micrometers or less.

Plasticizers

A nicotine lozenge 110 provided herein can also include one or moreplasticizers. Suitable plasticizers include propylene glycol, triacetin,glycerin, vegetable oil, partially hydrogenated oil, and medium chaintriglycerides. Esters of polycarboxylic acids with linear or branchedaliphatic alcohols of moderate chain length can also be used asplasticizers (OK)Moreover, plasticizers can facilitate the extrusionprocesses described below. In some cases, a nicotine lozenge 110provided herein can include up to 20 weight percent plasticizer. In somecases, the nicotine lozenge 110 includes between 0.05 and 10 weightpercent plasticizer, a nicotine lozenge 110 provided herein can includebetween 1 and 8 weight percent plasticizer, or between 2 and 4 weightpercent plasticizer.

Other Additives

A nicotine lozenge provided herein may optionally include otheradditives. For example, these additives can include non-nicotinealkaloids, dietary minerals, vitamins, dietary supplements, therapeuticagents, and fillers. For example, suitable vitamins include Vitamins A,B1, B2, B6, C, D2, D3, E, F, and K. For example, a nicotine lozenge 110provided herein can include C-vitamins. Suitable dietary mineralsinclude calcium (as carbonate, citrate, etc.) or magnesium (as oxide,etc.), chromium (usually as picolinate), and iron (as bis-glycinate).One or more dietary minerals could be included in a nicotine lozengewith or without the use of other additives. Other dietary supplementsand/or therapeutic agents can also be included as additives.

A nicotine lozenge provided herein can also include fillers such asstarch, di-calcium phosphate, lactose, sorbitol, mannitol, andmicrocrystalline cellulose, calcium carbonate, dicalcium phosphate,calcium sulfate, clays, silica, sodium lauryl sulfate (SLS), glycerylpalmitostearate, sodium benzoate, sodium stearyl fumarate, talc, andstearates (e.g., Mg or K), and waxes (e.g., glycerol monostearate,propylene glycol monostearate, and acetylated monoglycerides),stabilizers (e.g., ascorbic acid and monosterol citrate, BHT, or BHA),disintegrating agents (e.g., starch, sodium starch glycolate, crosscaramellose, crosslinked PVP), pH stabilizers, or preservatives. In somecases, the amount of filler in the nicotine lozenge 110 is limited toless than 10 weight percent in sum. In some cases, the amount of fillerin the nicotine lozenge 110 is limited to be less than 5 weight percentin sum. In some cases, the fillers are mouth stable. In some cases, thefillers can dissolve or disintegrate during use and thus result in anicotine lozenge that becomes more pliable during use.

PRODUCTION AND EXAMPLE

The nicotine lozenge 110 can be produced by forming a molten mixture ofsoluble fiber, water, and nicotine under controlled heating conditionssuch that a solution of soluble fiber, water, and nicotine is formedwithout degrading the nicotine or the soluble fiber. In some cases, atemperature of the molten mixture is maintained at a temperature below150° C. The molten mixture is then portioned into individual nicotinelozenges. Unlike many traditional lozenges, sugar and sugar alcohols arenot required to obtain a firm smooth-dissolving texture in processesprovided herein. Traditional lozenges can rely on the crosslinking ofsugars or sugar alcohols due to caramelization caused by heating tocaramelization temperatures. Caramelization temperatures, however, candegrade nicotine. A soluble-fiber matrix, however, can provide anicotine lozenge provided herein with a suitable dissolution time whenplaced in an adult consumer's mouth.

A molten mixture can be mixed and heated in any suitable but controlledmethod. In some cases, such as shown in FIG. 5, ingredients for a moltenmixture can be combined in an extruder and mixed in a continuousextrusion process. Unlike a traditional cooking method for many typicallozenges, a nicotine lozenge provided herein can have attributesprecisely controlled by extruder operation parameters, such as feedrate, barrel temperature profile, screw design, rpms, etc.

Referring to FIG. 5, an exemplary method 500 for making nicotinelozenges provided herein can include adding dry ingredients 512 ofsoluble fiber (e.g., maltodextrin) and color (e.g., TiO₂) to a firststation 510 a of an extruder 510, adding a first group of solutioningredients 514, including water and sweetener, at a second station 510b, and adding a second group of solution ingredients 516, includingnicotine, at a third station 510 c. A mixing extruder 510 can includemultiple stages controlled to be maintained at a predeterminedtemperature. As shown in FIG. 5, extruder 510 can include stages havingtemperatures ranging between 80° C. and 150° C. For example, dryingredients 512 and a first group of solution ingredients 514 can bemixed in a first stage of extruder 510 at a temperature of between 100°C. and 120° C., one or more subsequent stages can have a highertemperature (e.g., between 120° C. and 150° C.). Second group ofsolution ingredients 516, including nicotine, can be added downstream ofthe mixture of water with the soluble fiber. Adding certain ingredientsdownstream can limit degradation of certain ingredients (e.g., nicotine)due to exposure to heat.

A glass transition temperature (Tg) of molten mixture used to make anicotine lozenge provided herein can range from 50° C. to 120° C. (i.e.,about 122° F. to about 248° F.). FIG. 2, discussed above, is a DSC Chartfor an exemplary molten mixture that has a Tg range of between 50° C.and 120° C. FIG. 2A depicts the modulated DSC for an exemplary mixture,provided herein, which shows a Tg for a nicotine lozenge body that has aTg of 98° C.

A water content of a nicotine lozenge provided herein can be controlledin the extrusion process to ensure that the molten mixture has a glasstransition temperature of greater than human body temperature. In somecases, a molten mixture can have a water content of less than 15 weightpercent. In some cases, water content in a nicotine lozenge providedherein ranges from 2 weight percent to 15 weight percent. In some cases,water content in a nicotine lozenge provided herein ranges from 2 weightpercent to 20 weight percent.

After passing through the extruder, a molten mixture provided herein canhave a temperature of between its glass transition temperature and 150°C. In some cases, a molten mixture of between 85 and 90 weight percentdigestion-resistant maltodextrin can reach a maximum temperature in anextruder of between 100° C. and 150° C. and exit the extruder at thattemperature or lower. Because a molten mixture can remain above itsglass transition temperature as it exits the extruder, the moltenmixture can be reshaped after it exits the extruder. Molten mixture canpass onto a conveyor and move through a sheet forming apparatus 520.Sheet forming apparatus 520 can press the molten mixture into a sheethaving a predetermined thickness. For example, a predetermined thicknesscan be between 2 mm and 10 mm.

Individual nicotine lozenges 110 can be cut from a sheet of moltenmixture in portioning station 530. In some cases, a stamping die can cutone or more individual nicotine lozenges 110 to form a sheet. In somecases, a stamping die can press one or both sides of a sheet to both cuta nicotine lozenge and reshape edges to form rounded edges on thenicotine lozenges, such as those shown in FIG. 1. Cutting individualnicotine lozenges 110 can occur when the molten mixture is still aboveits Tg. Individual nicotine lozenges 110 can be cooled in a coolingstation 540 and packaged in a packaging station 550.

In addition to extrusion, there are other methods for mixing andcarefully controlling the temperature of a molten mixture used to formnicotine lozenges provided herein.

Other Embodiments

It is to be understood that, while the invention has been describedherein in conjunction with a number of different aspects, the foregoingdescription of the various aspects is intended to illustrate and notlimit the scope of the invention, which is defined by the scope of theappended claims. Other aspects, advantages, and modifications are withinthe scope of the following claims.

Disclosed are methods and compositions that can be used for, can be usedin conjunction with, can be used in preparation for, or are products ofthe disclosed methods and compositions. These and other materials aredisclosed herein, and it is understood that combinations, subsets,interactions, groups, etc. of these methods and compositions aredisclosed. That is, while specific reference to each various individualand collective combinations and permutations of these compositions andmethods may not be explicitly disclosed, each is specificallycontemplated and described herein. For example, if a particularcomposition of matter or a particular method is disclosed and discussedand a number of compositions or methods are discussed, each and everycombination and permutation of the compositions and the methods arespecifically contemplated unless specifically indicated to the contrary.Likewise, any subset or combination of these is also specificallycontemplated and disclosed.

What is claimed is:
 1. A nicotine lozenge, comprising a body that iswholly receivable in an oral cavity, the body comprising: a maltodextrinmatrix; and nicotine or a derivative thereof dispersed in themaltodextrin matrix such that the nicotine or derivative thereof isreleased from the body as the body dissolves when the body is at leastpartially received within the oral cavity of an adult tobacco consumerand exposed to saliva.